Peregrine announces promising trial data Print E-mail
By Staff and Wire Reports   
Wednesday, 15 June 2011 07:42
PPHMPeregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) has reported promising median overall survival (MOS) of 12.4 months from a Phase II clinical trial evaluating bavituximab plus carboplatin and paclitaxel in patients with previously untreated, locally-advanced or metastatic non-small cell lung cancer (NSCLC).
This survival is 20% longer than the 10.3 month MOS from a separate historic control trial using carboplatin and paclitaxel alone in a similar patient population. This new MOS data point is consistent with encouraging earlier data from this trial, including objective response rate (ORR) of 43% and median progression-free survival (PFS) of 6.1 months, versus historic control data of 15% ORR and 4.5 months PFS.

"A two month extension in patient survival is significant in this aggressive form of cancer and we are excited to have another therapy in later-stage clinical development to meet this urgent medical need," commented Raghunadharao Digumarti, M.D., principal investigator of this trial and professor and head of the Department of Medical Oncology at Nizam's Institute of Medical Sciences, Hyderabad, India. "As a novel monoclonal antibody targeting a novel universal target on all solid tumors, bavituximab is one of the most promising new therapeutic approaches for patients with lung and other forms of cancer."

Peregrine is currently enrolling patients in a randomized Phase II trial in front-line NSCLC evaluating this same therapeutic combination in up to 86 patients. In addition, bavituximab is being studied in combination with docetaxel in a randomized, double-blinded, placebo-controlled Phase II trial in second-line NSCLC and in combination with pemetrexed and carboplatin in a Phase Ib investigator-sponsored trial in front-line NSCLC.

"These survival data extend our set of bavituximab clinical data, and validate our strategy of advancing multiple clinical trials targeting NSCLC and other difficult to treat solid tumors," said Steven W. King, president and chief executive officer of Peregrine. "We are eager to complete enrollment over the coming weeks in our ongoing confirmatory Phase II trial evaluating this same therapeutic regimen in a larger, randomized study and reporting interim ORR results in the second half of this year. Our bavituximab oncology program is progressing well, with numerous company and investigator-sponsored trials evaluating the broad therapeutic potential of our first-in-class monoclonal antibody."

Peregrine's single-arm, open-label, multicenter Phase II trial enrolled 49 patients with stage IIIB/IV NSCLC. Overall, the safety profile of bavituximab when combined with carboplatin and paclitaxel did not appear to increase known chemotherapy toxicity.

Peregrine has developed proprietary therapeutic technologies as its core platforms which include: include phosphatidylserine (PS)-targeting therapy for cancers and for viral diseases and tumor necrosis therapy (TNT). Its clinical-stage platform technologies include phosphatidylserine (PS)-targeting therapy for cancers and viral diseases and tumor necrosis therapy (TNT). The company's targeted Tumor Necrosis Therapy technology (TNT) uses monoclonal antibodies designed to bind to DNA-histone H1 complex which is exposed primarily in the dead and dying cells that are present in abundance at the center of tumors.

Peregrine's product pipeline includes: Bavituximab Anti-Cancer, a monoclonal antibody that binds to phospholipids indicated for the treatment of solid tumours and breast cancer; Cotara®, an antibody attached to a radioactive molecule indicated for the treatment of brain cancer (Glioblastoma Multiforme); Bavituximab Anti-Viral, a monoclonal antibody indicated for the treatment of Hepatitis C and Hepatitis C Coinfected with HIV/AIDS.

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